A Study to Compare the Results of FGFR Testing by Either CtDNA Blood Testing or Standard Tumor Tissue Testing

Last updated: October 22, 2024
Sponsor: Bernie Eigl
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Urothelial Cancer

Treatment

FGFR Testing

Clinical Study ID

NCT06129084
ctDNA FGFR
  • Ages > 18
  • All Genders

Study Summary

A new drug, erdafitinib, became available for some patients with bladder cancer that has spread to other organs. To qualify, patients must have specific genetic changes in their tumors. Currently, doctors use tumor tissue samples to check for these genetic changes, but these samples might not accurately reflect the current state of the patient's cancer.

In this study, Investigators will test the patient's blood for these genetic changes in addition to the tumor tissue samples. It is thought that the blood test will give a more accurate result.

Investigators hope this study will help to find out if more patients can benefit from erdafitinib than the ones identified by tissue testing only.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with metastatic bladder cancer who are about to undergo tissue testing forFGFR mutations and who have blood samples drawn during the management of theirdisease are eligible to be included in this analysis.

Exclusion

Exclusion Criteria:

  • Metastatic bladder cancer patients who will not have tissue sent for FGFR testingwill be excluded from this study.

Study Design

Total Participants: 260
Treatment Group(s): 1
Primary Treatment: FGFR Testing
Phase:
Study Start date:
January 11, 2021
Estimated Completion Date:
May 01, 2025

Study Description

Recently, the first targeted therapy for patients with metastatic urothelial cancer (mUC) received approval, i.e. erdafitinib. Erdafitinib is a pan-FGFR small molecule inhibitor. Approximately twenty percent of mUC patients' tumors harbor qualifying alterations in FGFR2 or FGFR3. Currently, standard testing uses archival tumor tissue. However, this type of testing may not be representative of a patient's clinically dominant tumor clone at the time of treatment initiation due to temporal and spatial biopsy bias of archival tissue testing.

In this study, patients will undergo circulating tumor DNA testing, in addition to conventional tissue testing, for treatment eligibility. Investigators hypothesize that blood-based ctDNA testing will provide a more accurate assessment of somatic FGFR status than same patient archival primary tissue.

This study's objectives are:

Objective 1 (Primary): To evaluate the diagnostic value of ctDNA testing against the "gold standard" of tissue testing.

Objective 2 (Secondary): To evaluate whether ctDNA may be a superior predictive marker by identifying actionable FGFR alterations that are currently missed on tissue assays.

Procedures:

  • Medical history will be reviewed, including all previous anti-cancer treatments.

  • A blood sample will be collected for ctDNA testing at the time of screening for FGFR alterations and at progression under erdafitinib therapy. Test results will be compared to archival tissue testing.

Connect with a study center

  • Arthur J.E Child Comprehensive Cancer Centre

    Calgary, Alberta T2N 5G2
    Canada

    Active - Recruiting

  • Tom Baker Cancer Centre

    Calgary, Alberta T2N 4N2
    Canada

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • BC Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • London Health Sciences Centre

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • CHU de Québec-Université Laval

    Québec City, Quebec G1R 2J6
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.